Greetings. Welcome to Palatin's third quarter fiscal year 2023 operating results conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate, and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now I would like to turn the call over to Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead. Thank you. Good morning, welcome to the Palatin third quarter fiscal 2023 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Executive Vice President, Chief Financial Officer, and Chief Operating Officer. I will now turn the call over to Steve, and he'll give the financial and operating update. Steve. Thank you, Carl. Hello, everyone. Regarding financial highlights, I'll start with Vyleesi, and Vyleesi is our FDA-approved commercial product for premenopausal women with Hypoactive Sexual Desire Disorder or HSDD. The goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of licensing the U.S. rights to a committed woman's healthcare company. For the third quarter, and in March 31st, 2023, gross product sales were $3.4 million, an increase of 31% over the prior quarter and an increase of 165% over the comparable quarter last year. Net product revenue of $1.2 million increased 16% over the prior quarter and increased 453% over the comparable quarter last year. Total prescriptions dispensed increased 27% over the prior quarter and increased 147% over the comparable quarter last year. We have achieved five consecutive quarters of double-digit growth. Refill rates, commercial insurance reimbursement, and net revenue per prescription dispense continued with positive and impactful results and trends versus the prior quarter and comparable quarter last year. We are particularly pleased that Vyleesi's quarterly net product revenue exceeds Vyleesi's quarterly operating expenses. Yep, that means we are not losing any money on Vyleesi. Also, we were issued a patent titled Use of bremelanotide in Patients with Controlled Hypertension with a term through April 29th, 2041. Palatin did receive $4.7 million in January 2023 from the State of New Jersey's Technology Business Tax Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority. Moving over to the actual financial operating results for the third quarter and in March 31st, 2023. Regarding revenue, total revenue consists of gross product sales of Vyleesi, net of allowances and accruals and license and contract revenue. I covered the Vyleesi revenue numbers prior. Regarding operating expenses, total operating expenses were $8.5 million, compared to $8 million for the comparable quarter last year. The increase in operating expenses was mainly the result of higher spending on our marketing efforts of Vyleesi. Regarding cash flows, Palatin's net cash used in operations was $1.4 million, compared to net cash used in operations of $9.5 million for the same period last year. The decrease in net cash used in operations is mainly due to the company's receipt of proceeds from the state of New Jersey NOL, stands for Net Operating Losses and working capital changes for the quarter ended March 31st, 2023. Regarding net loss, Palatin's net loss was $7.1 million or $0.63 per basic and diluted common share, compared to a net loss of $7.6 million or $0.80 per basic and diluted common share for the comparable quarter last year. The decrease in net loss of the comparable quarter last year was mainly due to an increase in net product revenue of Vyleesi of $1 million, offset by an increase in operating expenses of approximately $500,000. Regarding Palatin's cash position, as of March 31st, 2023, cash and cash equivalents were approximately $19.6 million, plus approximately $1.7 million of accounts receivable. This was compared to cash and cash equivalents of $21.2 million, with $6.5 million of accounts and other receivables as of December 31st, 2022, and $29.9 million, with $1.8 million of accounts receivable as of June 30th, 2022. Based on our current operating plan, we believe that existing cash and cash equivalents and receivables will be sufficient to fund currently anticipated operating expenses through calendar year 2023. I'll turn the call back over to Carl. Thank you, Steve. At Palatin, we are focused on establishing the melanocortin system as a target for safe and effective medicines to treat inflammatory and autoimmune diseases, and to develop a pipeline of highly effective drugs with unparalleled safety. Through research in our laboratory and in collaboration with academic thought leaders, we continue to advance our understanding of the melanocortin system to identify opportunities for novel innovative therapeutics. Our research efforts are helping us to design better clinical trials and are becoming a key support for our business development activities. We have three active clinical programs based on melanocortin agonists developed from our research. In addition, we have two new ocular programs ready, pending resources to begin the activities required to start clinical studies. We are actively enrolling patients in the following clinical trials: MELODY-1, a phase III study in dry eye disease. A phase II study evaluating oral PL-8177, a selective melanocortin 1 receptor agonist in ulcerative colitis patients, and BREAKOUT, a phase II study in diabetic patients with kidney disease. We anticipate all three clinical studies will have data readouts in calendar 2023. Moving on to some of the highlights for the third quarter. Vyleesi continues to show impressive growth. As Steve mentioned, five quarters of double-digit increases in all key metrics, and we anticipate this growth will continue. We continue to make significant progress in establishing the melanocortin system as an innovative target for therapeutics to treat a variety of inflammatory diseases. As I said, we are enrolling patients in three clinical studies. Our ocular programs continue to make some impressive advances this quarter. We are very excited by the emerging product profile for PL-9643, our melanocortin-based therapeutic for dry eye disease. PL-9643 is highly differentiated from current treatments with excellent ocular tolerability and broad efficacy that we believe will make PL-9643 the leading treatment for dry eye disease. We presented data from the analysis of the lead-in population of the PL-9643 MELODY-1 Phase 3 trial at the annual meeting of the Association for Research in Vision and Ophthalmology. PL-9643 demonstrated broad efficacy with statistical separation across multiple signs and symptoms of dry eye disease and an excellent ocular tolerability and safety profile with no ocular adverse events. This analysis was important, allowing us to confidently set the primary sign and symptom endpoints, hierarchical ordering of secondary endpoints, analysis methods, and sample size for the double-blind segment of the MELODY-1 phase III trial. We also hosted a key opinion leader event for investors where the very exciting data from MELODY-1 phase III trial was presented. If you've missed this event, a link for the replay can be found on our website. We also presented data at ARVO on PL-9588, our melanocortin-based treatment for glaucoma. In a preclinical rabbit studies, PL-9588 showed competitive effects on intraocular pressure with a single topical dose lowering intraocular pressure with a magnitude similar to or greater than the positive controls, latanoprost and timolol, with the effect lasting up to 24 hours. This important program is now ready to advance into pre-IND activities on the way to clinical trials. Our non-ocular melanocortin programs also made significant advances with multiple presentations at scientific meetings and publications in peer-reviewed journals, as well as continuing to enroll patients in phase II trials. Our expertise in the melanocortin system and our innovative clinical programs are supporting our business development activities. Discussions with potential partners for our programs has increased, and we remain optimistic that we will enter into one or more partnerships to advance our programs. I'd like to thank you for listening to the Palatin third quarter fiscal 2023 conference call. You can find additional information on our science and clinical programs on our website www.palatin.com. You can also find additional information on Vyleesi at the vyleesi.com website. Steve and I would like to thank you, and we'll now open the call to questions. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. Your first question for today is coming from Joe Pantginis at H.C. Wainwright. Hey, guys. Good afternoon. Thanks for taking the question. First want to start with Vyleesi. Nice to see the continued early traction here. Just curious, what is the% inventory that you're usually keeping? You know,% in the distribution centers, and what are your current plans to improve or ongoing efforts to improve your gross to net at this point? Hey, Joe, it's Steve. Thanks for the question there. The way our distribution is set up, we actually only have one specialty pharmacy called Knipper. We actually sell to the Knipper 3PL, and then the Knipper 3PL, if you will, sells to the pharmacy. We do what I believe a very good job of making sure our dispenses for the month, the quarter, pretty much match up with the sales, which is how we actually report it. For the first quarter, March 31st, 2023, we had prescriptions dispensed of a little under 4,000 for the quarter, and that's pretty much what we had that we had sold to the 3PL. There's just a point or two difference in that regard. To sum it up, we have virtually nothing in the distribution chain that's not already been sold. Yeah, go ahead, sorry. Part B of your question is what else are we doing? Well, Our strategy, as we've been very clear, we're not looking to put significant numbers of salespeople, feet on the ground, if you will. Our target is to do a very informed and measured digital social media campaign. We spend a lot of time trying to make sure we have the right algorithms, if you will, for when patients are searching for this condition and a treatment option, that they land on Vyleesi. We do have a few sales folk, but they're mainly inside and remote, albeit they do a little bit of traveling. We're gonna continue the digital and social media. You know, since our metric is to show value, have somebody be able to, upon review, get very comfortable that they can extrapolate the numbers based on what we're doing, we think we can do that, we can show that. It's been successful from our target model standpoint. We. Five consecutive quarters of double-digit growth, that's both at the net sales level and also with prescriptions dispensed. We are increasing demand, but that's not our top metric. Our metric was to make sure we got significant insurance coverage, making it as accessible to the patient as possible. We now have over two-thirds of all our dispenses are covered by insurance. 3/4 of those dispenses, the patient actually pays zero. We think we have some very robust insurance coverage in that regard. we're gonna continue the path, Joe, which is increasing demand a bit, making sure that our net gross to net number is good. we're now into the position where we're not losing any money on Vyleesi. you know, looking forward to the time when someone sees the value that we've had yield, and we end up doing a licensing collaboration or sale of the asset at some point in the future. No, great. I appreciate that color. You know what? My second question, I'm gonna hop over dry eye 'cause you guys just recently held a KOL event on that. I'm gonna ask a quick question on PL-8177 for ulcerative colitis. Just curious, when you guys announce later this year the first data set, what kind of metrics are we gonna be potentially given? Joe, this is Carl. This is predominantly a proof of concept study, and it's really done by imaging. It's a colonoscopy, and we're looking at biopsy and reduction of inflammation and damage to lesions. It's a simple Mayo score. You also get additional things like reductions in, you know, bloody stools and so on and other common metrics that are used in these studies. It's predominantly this is really a study that's really looking for, you know, direct evidence of the reduction of the inflammation and damage that's occurring in the colon. Great. Thanks, guys. Your next question for today is coming from Michael Higgins at Ladenburg Thalmann. Thanks, Avery. Thanks, guys, for taking the questions. Congrats again on all the pipeline progress this spring. You've certainly kept us quite busy. Thanks for putting together the KOL event. It's very helpful. Not much new in the press release here. We do have two questions. The first will follow along the lines of Joe's thinking on what we're seeing here, the allowance for product returns. We're seeing it as a relatively high percent of gross sales. Seems to be sticky there despite the time since launch. Certainly it accounts for potential returns, may include expiration dates as well as potential overstocking, of course. Surprised to see the rate on gross sales remain so high for so long. Just trying to get an understanding of why that is, and then more importantly, when it might come down as that will accelerate the reported net sales. Thanks. Yeah, Michael, I'm not sure I'm following your question regarding the stickiness or the gross sales. It actually is, we're increasing every quarter the gross sales. The net sales are increasing, for the most part, every quarter, hence the double-digit growth. We have very little allowances for returns because we don't have much in from a return standpoint. If you could clarify the question, a bit more, I'd appreciate. Again, we have our gross net sales every quarter. The spreads are getting, you know, better other than the first quarter. The difference. We did have a lower yield for net sales for the first quarter, but that was 100% attributable to the first quarter. The insurance reimbursement was not as high, and that's primarily because of the deductibles that normally hit in the first quarter, first half of the year. As I look at it, the second quarter, we're back up to where we were prior. Sure. The allowance for product returns is a accounting measure that's been used for all product launches, and it provides the investors or anyone, I guess, some insights from the accountants into what potentially may be returned, and it's highly regulated. It's something that's not something that it's very subjective. It comes directly from dating and then also just returns what's coming back. A pharmacy may oversubscribe, then it goes back. Usually, that wears off after the first, say, 12 months. We're past that now, so seeing it still up there is a bit surprising. We've not modeled it. We're pretty conservative in that. Eventually, that drops. Here, so far, we're about 75% of gross sales is allowance for product returns, where at this stage of the launch, typically it's below half. At some point that should turn, and when that does, that hits net sales. It's a great accelerator. We're just trying to gauge when that might come. Thanks. I can help you when it might not come. It's not gonna come. The data that you're referencing is not accurate. 100% not accurate. We have zero, in the channel. The 3PL that we sell to, they pretty much just buy what they need for the week based on the sales that are gonna be going over to the pharmacy. We're able to do that since we only have one pharmacy. From a distribution standpoint, we have one 3PL, and they're both housed in the same industrial park, which is Knipper. I couldn't stress any greater. I have no problem with stating that that information is 100% inaccurate. We do not expect, anticipate any significant allowances coming back. There's nothing in the channel to do that, and we actually have very low patient returns of the product. Yeah, I'm just seeing the 10-Q this morning, that's what I'm referencing that, but appreciate the feedback there. Carl, one question for you. We're seeing a lot in the melanocortin pipeline advancing, of course, in ophthalmic conditions. You've expanded into osteoarthritis, diabetic nephropathy. Vyleesi obviously is approved in female sexual dysfunction. We're just wondering about the potential in obesity, given the rationale there and some success with melanocortin agents. Thanks. Sure. you know, Michael, you know, we've had conversations about this before. you know, clearly it's obesity, MC4R, and obesity is a very near and dear to the company and certainly to my heart. We've done a lot of research work there, and we are certainly in light of the expanse of the GLP-1 inhibitors class in the marketplace and the potential, you know, of, well, $100 plus billion market there. We are certainly actively looking at our options in that space. Our belief is based on what we s-- our research work and very recent discussions with prescribers of the GLP-1, that there is a very key and important role for melanocortin agonist in the treatment of obesity. We're evaluating that, and I would suggest to you you'll hear more about it in the upcoming quarters, as that plan comes into, you know, finalization. We are very interested in that, and we do think it's a phenomenal opportunity. Awesome. Appreciate the feedback. Thanks, guys. Yep. Once again, if there are any questions, please press star one on your telephone keypad. We have reached the end of the question and answer session. I will now turn the call over to management for closing remarks. Thanks. Steve, would like to make a quick statement? Yeah. I just, regarding Michael Higgins' question on the allowance and the accruals, what he's actually referencing is in our 10-Q, specifically on note, in the first notes, note 3, we break out between gross sales to net sales. Actually, for the three months ended March 31st, 2023, gross sales were $3.4 million, net sales were $1.2 million. The difference is what it costs us to go from gross to net. We have a WAC of $899, but we have to pay fees to the pharmacies, fees, reimbursement, if you will, to the PBMs, to the various insurance coverage and all the other very standard and customary expenses that you have when you go from gross to net. There is 100%, very little, if none, no charges related to allowances for that come back. Actually, if you look at our March 31st, 2023 quarter, the net sales as a percentage of the gross sales actually increased. The provision for all the various expenses was approximately 80% in the first quarter of March 2022, and it's now down to 65% for the first quarter of 2023. Very significant increases, all positive. I just wanted to clear that up, if you didn't mind. Thank you. Carl? Thanks, Steve. I'd like to thank everyone for participating in the third quarter fiscal 2023 call. You know, Steve and I couldn't be more excited about what we're doing. It was a tremendous quarter with progress on all the programs. I think, you know, we really seem to be hitting it pretty well right now, and we're quite enthusiastic about the future and what the rest of the year is gonna bring. With that being said, thank you all for participating. Steve and I would like you to have a great day, and we look forward to continue updating you on our progress and the, on the rest of 2023. Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.